DepressionENGAGE-TBANCT03378544
Engaging Traditional Birth Attendants to Reduce Maternal Depression in Rural Kenya
A study testing mhGAP in people with Depression, run by Africa Institute of Mental and Brain Health (AFRIMEB) at 1 site in Kenya.
Trial summary
Evidence from Low and Middle Income Countries has demonstrated the effectiveness of various psychosocial approaches for depression. However, there are no mental health specialists to deliver these interventions especially in rural African settings. Read more about this study
- Who is it for?
- Ages 14 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- mhGAP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteKenya
- Study dates
- 9 Apr 2018to 31 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 50 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Gestational age of between 16 and 26 weeks
- A positive score on EPDS
- Confirmed diagnosis of depression using the Mini International Psychiatric Interview
- Provision of an informed consent
Who cannot join
- Actively suicidal
- Severe mental disorders and/or medical conditions requiring immediate medical attention
- A negative score on EPDS
- Pregnancy-related complications
- Decline to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Evidence from Low and Middle Income Countries has demonstrated the effectiveness of various psychosocial approaches for depression. However, there are no mental health specialists to deliver these interventions especially in rural African settings. This study aims at testing the effectiveness of mental health Global Action Programme (mhGAP-IG) psychosocial interventions among Traditional Birth Attendants (TBAs) for pregnant mothers. The outcomes of this intervention will result into depression reduction in the mothers that will lead to better care during pregnancy and for their infants, allowing for long-term impact on their physical and the psychological wellbeing and that of their children.
Read the detailed description
Evidence from Low and Middle Income Countries has demonstrated the effectiveness of various psychosocial approaches for depression. However, there are no mental health specialists to deliver these interventions especially in rural African settings. This study aims at testing the effectiveness of mental health Global Action Programme (mhGAP-IG) psychosocial interventions among Traditional Birth Attendants (TBAs) for pregnant mothers seeking the services of TBAs and suffering from maternal depression.
A cluster randomized controlled trial with two sub-counties in Makueni County (rural Kenya) as the clusters, randomized into either intervention or control arms will be used. TBAs in the intervention arm will receive training on mhGAP-IG while those in the control arm will only be requested to refer patients to nearest clinics and continue with their routine care, except in circumstances of pregnancy-related complications or severe medical conditions. All pregnant mothers will be eligible for inclusion.
Qualitative measures will be used to explore community and other stakeholder views regarding the integration of TBAs into mental health care and promoting dialogue with the formal health sector. Various questionnaires will be administered at 0, 3, 6 and 9 months in order to test the effectiveness of the intervention at various intervals. Interviews will be conducted at 9 months for randomly selected mothers receiving the intervention and those in the control arm, for purposes of describing and evaluating their experiences regarding use of TBA and health care workers' services. The survival and physical wellbeing of the baby will also be measured using the labour process, birth and subsequent weight of the baby, completed schedules of immunization and developmental milestones until 6 months.
The outcomes of this intervention will result into depression reduction in the mothers that will lead to better care during pregnancy and for their infants, allowing for long-term impact on their physical and the psychological wellbeing and that of their children.
- Conditions
- Depression
- Being tested
- mhGAP
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mhGAPBehavioural
The intervention will involve psycho-education to patients on the importance of maintaining interest in activities that they used to do, regular sleep cycles, physical activity and social activity
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | Patients with suicidal ideation and depression will receive psychosocial interventions adapted from the WHO mental health Global Action Programme Intervention Guide (mhGAP-IG). The intervention will involve psycho-education to patients on the importance of maintaining interest in activities that they used to do, regular sleep cycles, physical activity and social activity. Receives: Behavioral: mhGAP |
| Control group | No intervention | Patients with suicidal ideation and depression will be trained on how to refer patients suffering from depression, using a referral note to the nearest health centre for further treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in depressive symptoms
The proportion of patients (mothers with maternal depression) with reduction of depressive symptoms at 3, 6, and 9 months from baseline, using the Edinburgh Postnatal Depression Scale. This tool has adequate sensitivity and specificity to identify depressive symptoms in the antenatal and postnatal periods. A score is calculated by adding the individual items for each question. A total score of 11 or more in the Kenyan context is considered a flag for the need for follow up of possible depressive symptoms.
Measured: 0, 3, 6, and 9 months
Secondary outcomes (5)
Intimate Partner violence
The proportion of depressed patients at the TBA clinics experiencing intimate partner violence using the World Health Organization instrument to measure partner violence. This questionnaire measures violence from various aspects such as (i) physical, sexual, emotional, controlling behaviours and physical violence in pregnancy; (ii) physical and forms of violence by non-partners since age 15 years and (iii) Childhood sexual abuse before age 15 years. A "yes" in any of the items in the specific forms of violence indicates a positive score for that type of violence.
Measured: Baseline
Quality of life of mothers with depression
Change from baseline to 3, 6, and 9 months in quality of life domains using the World Health Organization Quality of Life questionnaire. The minimum and maximum scores for physical, psychological, social and environmental domains are (7-35), (6-30), (3-15) and (8-40) respectively. The domains are scored through a simple algebraic summation of each item in that scale and the raw scores transformed into a 0-100 scale by subtracting lowest possible raw score from actual raw score and dividing the total by the possible raw score range, then the total is multiplied by 100. Higher scores on each of the domains indicate higher quality of life.
Measured: 0, 3, 6, and 9 months
Satisfaction levels
Change in satisfaction levels among patients seeking TBA services
Measured: 0, 3, 6, and 9 months
Suicidality
The proportion of patients with reduced suicidal behaviors such as ideations or attempts as measured using the Beck's Suicidality Scale at 3, 6, and 9 months. This scale assesses a patient's thoughts, plans and intent to commit suicide. There are no specific cut-off scores for severity classification. Therefore, the total scores calculated through summation of the items range from 0 to 42. Increasing scores reflect greater suicide risk.
Measured: 0, 3, 6, and 9 months
Disability
Change from baseline to 6, and 9 months in disability scores using the World Health Organization Disability Assessment Schedule. This scale asks difficulties related to health/mental conditions. The "item-response-theory" (IRT)-based scoring which takes into account multiple levels of difficulty for each item is used. After summing the scores for all six different functioning domains: cognition, mobility, self-care, getting along, life activities (household and work/school) and participation, the summary scores are converted into a metric ranging from 0 to 100 (where 0 = no disability; 100 = full disability). High scores on a particular domain indicate significant and problematic areas for the individual.
Measured: 0, 6, and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2017
- Study start9 Apr 2018
- Primary completion31 Aug 2019
- Study completion31 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A cluster randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Africa Institute of Mental and Brain Health (AFRIMEB)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christine W Musyimi, Principal investigator, Africa Institute of Mental and Brain Health (AFRIMEB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03378544
- Sponsor's protocol ID
- AfricaMHF
- Acronym
- ENGAGE-TBA
- Status last verified
- Sep 2025
- First submitted
- 5 Dec 2017
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Engaging Traditional Birth Attendants to Reduce Maternal Depression in Rural Kenya
- ClinicalTrials.gov ID
- NCT03378544
- Acronym / sponsor ID
- ENGAGE-TBA / AfricaMHF
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Africa Institute of Mental and Brain Health (AFRIMEB)University, hospital or other
- Study start
- 9 Apr 2018 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 20 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evidence from Low and Middle Income Countries has demonstrated the effectiveness of various psychosocial approaches for depression. However, there are no mental health specialists to deliver these interventions especially in rural African settings. This study aims at testing the effectiveness of mental health Global Action Programme (mhGAP-IG) psychosocial interventions among Traditional Birth Attendants (TBAs) for pregnant mothers. The outcomes of this intervention will result into depression reduction in the mothers that will lead to better care during pregnancy and for their infants, allowing for long-term impact on their physical and the psychological wellbeing and that of their children.
Detailed description
Evidence from Low and Middle Income Countries has demonstrated the effectiveness of various psychosocial approaches for depression. However, there are no mental health specialists to deliver these interventions especially in rural African settings. This study aims at testing the effectiveness of mental health Global Action Programme (mhGAP-IG) psychosocial interventions among Traditional Birth Attendants (TBAs) for pregnant mothers seeking the services of TBAs and suffering from maternal depression.
A cluster randomized controlled trial with two sub-counties in Makueni County (rural Kenya) as the clusters, randomized into either intervention or control arms will be used. TBAs in the intervention arm will receive training on mhGAP-IG while those in the control arm will only be requested to refer patients to nearest clinics and continue with their routine care, except in circumstances of pregnancy-related complications or severe medical conditions. All pregnant mothers will be eligible for inclusion.
Qualitative measures will be used to explore community and other stakeholder views regarding the integration of TBAs into mental health care and promoting dialogue with the formal health sector. Various questionnaires will be administered at 0, 3, 6 and 9 months in order to test the effectiveness of the intervention at various intervals. Interviews will be conducted at 9 months for randomly selected mothers receiving the intervention and those in the control arm, for purposes of describing and evaluating their experiences regarding use of TBA and health care workers' services. The survival and physical wellbeing of the baby will also be measured using the labour process, birth and subsequent weight of the baby, completed schedules of immunization and developmental milestones until 6 months.
The outcomes of this intervention will result into depression reduction in the mothers that will lead to better care during pregnancy and for their infants, allowing for long-term impact on their physical and the psychological wellbeing and that of their children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A cluster randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Behavioral: mhGAPPatients with suicidal ideation and depression will receive psychosocial interventions adapted from the WHO mental health Global Action Programme Intervention Guide (mhGAP-IG). The intervention will involve psycho-education to patients on the importance of maintaining interest in activities that they used to do, regular sleep cycles, physical activity and social activity. |
| Control group | No intervention | –Patients with suicidal ideation and depression will be trained on how to refer patients suffering from depression, using a referral note to the nearest health centre for further treatment |
Who may qualify
- Ages
- 14 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Gestational age of between 16 and 26 weeks
- A positive score on EPDS
- Confirmed diagnosis of depression using the Mini International Psychiatric Interview
- Provision of an informed consent
Key exclusion criteria (5 listed)
- Actively suicidal
- Severe mental disorders and/or medical conditions requiring immediate medical attention
- A negative score on EPDS
- Pregnancy-related complications
- Decline to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mhGAPThe intervention will involve psycho-education to patients on the importance of maintaining interest in activities that they used to do, regular sleep cycles, physical activity and social activity | Behavioural | Experimental arm |
Primary outcome
Reduction in depressive symptoms
Time frame: 0, 3, 6, and 9 months
The proportion of patients (mothers with maternal depression) with reduction of depressive symptoms at 3, 6, and 9 months from baseline, using the Edinburgh Postnatal Depression Scale. This tool has adequate sensitivity and specificity to identify depressive symptoms in the antenatal and postnatal periods. A score is calculated by adding the individual items for each question. A total score of 11 or more in the Kenyan context is considered a flag for the need for follow up of possible depressive symptoms.
5 secondary outcomes
Intimate Partner violence
Time frame: Baseline
Quality of life of mothers with depression
Time frame: 0, 3, 6, and 9 months
Satisfaction levels
Time frame: 0, 3, 6, and 9 months
Suicidality
Time frame: 0, 3, 6, and 9 months
Disability
Time frame: 0, 6, and 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine W Musyimi principal investigator
Africa Institute of Mental and Brain Health (AFRIMEB)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mhGAP in people with Depression, run by Africa Institute of Mental and Brain Health (AFRIMEB) at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in depressive symptoms (time frame: 0, 3, 6, and 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.